FDA — authorised 2 December 2015
- Application: NDA021265
- Marketing authorisation holder: SANDOZ CANADA INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA authorised Infuvite Adult on 2 December 2015
The FDA approved Infuvite Adult, a multiple vitamins injection, for intravenous use. APOTEX submitted an Abbreviated New Drug Application (ANDA) with the application number ANDA210273. The approval was granted on 2026-04-09. Infuvite Adult is indicated for intravenous use.
The FDA approved Infuvite Adult, a multiple vitamins injection, for intravenous use in adults. The product is manufactured by APOTEX and was approved under the standard expedited pathway. The approval was granted on 2026-04-09, with application number ANDA210672.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 2 December 2015; FDA authorised it on 9 April 2026; FDA authorised it on 9 April 2026.
SANDOZ CANADA INC holds the US marketing authorisation.